CLINICAL TRIALS PROFILE FOR PORACTANT ALFA

Clinical Trials for Poractant Alfa

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome
(RDS) in premature infants greatly improved survival rates. Newer surfactants approved by
the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of
newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a
double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared
to infants treated with Survanta, the most commonly used surfactant preparation in the
United States. While the data was suggestive, it was not clear that the improvement in
survival was reproducible or that Curosurf was responsible for the improved survival rates.
The purpose of this study was to investigate the role of Curosurf in improving lung function
and survival rates and reducing the complications of prematurity in very premature infants <
30 weeks gestational age at birth.

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome
(RDS) in premature infants greatly improved survival rates. Newer surfactants approved by
the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of
newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a
double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared
to infants treated with Survanta, the most commonly used surfactant preparation in the
United States. While the data was suggestive, it was not clear that the improvement in
survival was reproducible or that Curosurf was responsible for the improved survival rates.
The purpose of this study was to investigate the role of Curosurf in improving lung function
and survival rates and reducing the complications of prematurity in very premature infants <
30 weeks gestational age at birth.

Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in
newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change
the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or
bolus poractant alfa changes the duration of mechanical respiratory support or other
outcomes in MAS.

A multicenter, double blind, randomized, single dose, active-controlled study to investigate
the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine
surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with
respiratory distress syndrome. Main objectives of this study are to investigate the short
term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in
terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term
efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and
mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36
weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of
prematurity.
Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either
sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with
RDS, requirement of endotracheal surfactant administration within 24 hours from birth,
fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for
babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%.

Trial ID

Title

Status

Sponsor

Phase

Summary

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